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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020969
Company: MALLINCKRODT HOSP

Products on NDA 020969

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
UVADEX	METHOXSALEN	0.02MG/ML	INJECTABLE;INJECTION	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020969

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/25/1999	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20969lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20969ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20969.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/19/2021	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020969s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020969Orig1s014ltr.pdf
01/09/2018	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020969s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020969Orig1s10ltr.pdf
11/01/2013	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020969s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020969Orig1s006ltr.pdf
06/05/2013	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 020969

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/19/2021	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020969s014lbl.pdf
01/09/2018	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020969s010lbl.pdf
11/01/2013	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020969s006lbl.pdf
02/25/1999	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20969lbl.pdf

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